NCT07394543

Brief Summary

Acute myocarditis is a major cause of death in young adults and carries substantial morbidity, including a significant risk of progression to dilated cardiomyopathy. Current diagnostic and therapeutic strategies remain poorly defined, making risk stratification crucial to enable personalized treatments and reduce mortality and major cardiovascular events.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Feb 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026Feb 2036

First Submitted

Initial submission to the registry

January 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2036

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

10 years

First QC Date

January 30, 2026

Last Update Submit

January 30, 2026

Conditions

Myocarditis Acute

Keywords

Late Gadolinium EnhancementMyocarditis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    All-cause mortality defined using the French national registry of death (INSEE).

    From enrollment to the end of follow up at 10 years

Secondary Outcomes (4)

  • All-cause death

    From enrollment to the end of follow up at 10 years

  • Heart transplantation

    From enrollment to the end of follow up at 10 years

  • Ventricular arrhythmia

    From enrollment to the end of follow up at 10 years

  • Hospitalisation for acute heart failure

    From enrollment to the end of follow up at 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include all consecutive patients with AM referred for CMR assessment.

You may qualify if:

  • Age ≥ 18 years
  • Ability to provide informed non-opposition
  • AM diagnosis confirmed using CMR, fulfilling the modified Lake Louise diagnostic criteria

You may not qualify if:

  • \. Patients unable to provide informed non-opposition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Théo PEZEL, Dr

CONTACT

+33 6 68 72 24 89theo.pezel@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 6, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

February 10, 2036

Study Completion (Estimated)

February 10, 2036

Last Updated

February 6, 2026

Record last verified: 2026-01